NCT02167594

Brief Summary

This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 12, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2016

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

August 28, 2020

Completed
Last Updated

August 28, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

June 17, 2014

Results QC Date

July 16, 2020

Last Update Submit

August 21, 2020

Conditions

Progressive Supranuclear PalsyCorticobasal Degeneration

Outcome Measures

Primary Outcomes (1)

  • Flortaucipir Imaging in PSP, CBD and Healthy Volunteers

    A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

    baseline and 9 month scans

Study Arms (3)

PSP Subjects

EXPERIMENTAL

Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.

Drug: Flortaucipir F18Procedure: Brain PET scan

CBD subjects

EXPERIMENTAL

Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.

Drug: Flortaucipir F18Procedure: Brain PET scan

Healthy volunteers

EXPERIMENTAL

Healthy volunteers receiving a flortaucipir PET scan at baseline.

Drug: Flortaucipir F18Procedure: Brain PET scan

Interventions

Flortaucipir F18DRUG

IV injection, 370 megabecquerel (MBq) (10 mCi)

Also known as: [F18]T807, 18F-AV-1451, LY3191748, Tauvid
CBD subjectsHealthy volunteersPSP Subjects
Brain PET scanPROCEDURE

positron emission tomography (PET) scan of the brain 75-105 minutes post-injection

CBD subjectsHealthy volunteersPSP Subjects

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cognitively Healthy Volunteers
  • Mini-mental state examination (MMSE) ≥ 28
  • No history of cognitive decline or parkinsonian motor disorder
  • CBD and PSP subjects
  • Able to walk 10 steps with minimal assistance
  • MMSE ≥ 14 and ≤ 30
  • Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject
  • PSP subjects only
  • Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial
  • CBD subjects only
  • Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype

You may not qualify if:

  • All subjects
  • Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI
  • Claustrophobia
  • Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval \>450 msec)
  • Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)
  • Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
  • Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
  • Have a history of neuroleptic use for a prolonged period of time or within the past 6 months
  • PSP and CBD subjects
  • Have evidence of amyloid deposition
  • Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease
  • Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits
  • Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

UCSD Movement Disorder Clinic

La Jolla, California, 92037, United States

Location

UCSF Neurosciences Clinical Research Unit

San Francisco, California, 94158, United States

Location

Molecular Neuroimaging

New Haven, Connecticut, 06510, United States

Location

Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Supranuclear Palsy, ProgressiveCorticobasal Degeneration

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersOphthalmoplegiaOcular Motility DisordersCranial Nerve DiseasesTauopathiesNeurodegenerative DiseasesParalysisNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Medical Director
Organization
Avid Radiopharmaceuticals, Inc.
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Medical Director

    Avid Radiopharmaceuticals, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 19, 2014

Study Start

August 12, 2014

Primary Completion

July 11, 2016

Study Completion

July 11, 2016

Last Updated

August 28, 2020

Results First Posted

August 28, 2020

Record last verified: 2020-08

Locations

US(5)